Methods for treatment of cognitive and menopausal disorders with D-threo methylphenidate

a technology of dthreomethylphenidate and cognitive and menopausal disorders, which is applied in the direction of biocide, drug composition, metabolic disorders, etc., can solve the problems of inability to achieve high activity, inability to tolerate pain, so as to reduce the potential for abuse, the effect of reducing the euphoric effect and high activity levels

Inactive Publication Date: 2006-08-17
CELGENE CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0010] It has been discovered that the use of the D-threo isomer (2R:2′R) of methylphenidate, substantially free of the 1-threo isomer, produces a methylphenidate medication which retains high activity levels and simultaneously may possess reduced euphoric effect and reduced potential for abuse among pati

Problems solved by technology

Advanced cancer typically produces severe pain in patients.
However, the pain relief is often accompanied by undesirable side-effects such as unacceptable sedation and/or a decrease in cognitive function.
These side effects have a significant negative impact on the quality of life of the patient.
Menopause is accompanied by several side effects, including an executive function defect.
For example, many menopausal women report impairment in short term memory, inability to screen distractions and sustain attention in organization of thoughts and tasks.
Undesirable side effects associated with the use of the DL-threo

Method used

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  • Methods for treatment of cognitive and menopausal disorders with D-threo methylphenidate

Examples

Experimental program
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Effect test

example 1

Administration of D-threo-methylpbenidate hydrochloride (d-MPH) in the Treatment of Cognitive Dysfunction Related to Chemotherapy in Adult Cancer Patients

[0060] Patients that have received at least one cycle of cytotoxic chemotherapy, preferably within 2 months prior to treatment, and who display one or more symptoms of cognitive dysfunction are evaluated as candidates for d-MPH treatment. Prior to commencement of treatment, patients are evaluated for the following: medical history / concomitant illnesses, physical examination, 12-lead electrocardiogram, routine laboratory tests and assessments of cognitive function. Tests for cognitive function can include those know to those of skill in the art, for example those described above. Patients having no medical contraindication to the use of methylphenidate are then initially administered d-MPH 5 mg / day (2.5 mg b.i.d given 4 to 6 hours apart). The dose may be increased as clinically warranted if there are no adverse effects that preclud...

example 2

Administration of D-threo-methylphenidate hydrochloride (d-MPH) in the Treatment of Menopausal Women

[0062] Menopausal women who display one or more symptoms including an executive function defect, decreased cognitive function, mental depression, vasomotor instability, nervousness, excitability, fatigue, neurobehavioral slowing, apathy, or impairment of short term memory are evaluated as candidates for d-MPH treatment. Prior to commencement of treatment, patients are evaluated for the following: medical history / concomitant illnesses, physical examination, 12-lead electrocardiogram, routine laboratory tests and assessments of the severity of the symptom.

[0063] Patients having no medical contraindication to the use of methylphenidate are then initially administered d-MPH 5 mg / day (2.5 mg b.i.d given 4 to 6 hours apart). The dose may be increased as clinically warranted if there are no adverse effects that preclude dose-escalation and there is no significant therapeutic response. Dail...

example 3

Administration of D-threo-methylphenidate hydrochloride (d-MPH) in the Treatment of Menopausal Women having previously diagnosed Attention Deficit Disorder (ADD)

[0065] Menopausal women who have been previously been diagnosed with Attention Deficit Disorder (“ADD”) and who are suspected having exacerbated ADD symptoms are evaluated for one or more symptoms of ADD according to previously published methods (for example, see American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). Washington, D.C., 1994, pp 78-85).

[0066] Patients having no medical contraindication to the use of methylphenidate are then initially administered d-MPH 5, mg / day (2.5 mg b.i.d given 4 to 6 hours apart). The dose may be increased as clinically warranted if there are no adverse effects that preclude dose-escalation and there is no significant therapeutic response. Daily doses can be administered two or three times per day. The maximum dose will generall...

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Abstract

In one aspect, the present invention is directed to methods for treating fatigue, neurobehavioral slowing and other cognitive disorders and defects due to cancers and treatments associated with cancers, and similar conditions. In a further aspect, the present invention is directed to methods for treating disorders related to menopause, including executive function defects. The methods involve the administration of a composition comprising D-threo methylphenidate that is substantially free of L-threo methylphenidate and of erythro forms of methylphenidate.

Description

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation in part of U.S. Ser. No. 09 / 318,151, filed May 25, 1999, which is a continuation in part of U.S. Ser No. 08 / 583,317 filed Jan. 5, 1996, now U.S. Pat. No. 5,773,756, and a continuation in part of U.S. Ser. No. 08 / 827,230, filed Apr. 2, 1997, now U.S. Pat. No. 5,908,850, which is continuation of U.S. Ser. No. 08 / 567,131, filed Dec. 4, 1995. The contents of each of the foregoing applications are incorporated herein by reference in their entirety.FIELD OF THE INVENTION [0002] In one aspect, the present invention is directed to methods for treating fatigue, neurobehavioral slowing and other cognitive disorders and defects due to cancers and treatments associated with cancers, and similar conditions. In a further aspect, the present invention is directed to methods for treating disorders related to menopause, including executive function defects. The methods involve the administration of a composition compri...

Claims

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Application Information

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IPC IPC(8): A61K31/445A61K31/4458C07D211/34A61K45/06A61P3/00A61P9/00A61P15/12A61P25/20A61P25/22A61P25/24A61P25/28A61P35/00C12P17/12C12P41/00
CPCA61K31/4458A61K45/06C07D211/34C12P17/12C12P41/006A61K2300/00A61P15/00A61P15/12A61P25/00A61P25/04A61P25/20A61P25/22A61P25/24A61P25/26A61P25/28A61P3/00A61P35/00A61P35/04A61P9/00
Inventor ZELDIS, JEROME B.ZEITLIN, ANDREW L.FALECK, HERBERT J.KHETANI, VIKRAMDARIANI, MAGHSOUD M.STERLING, DAVID I.
Owner CELGENE CORP
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